BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS

    MDR report key: 15927727 · Received December 6, 2022

    Report

    Report Number
    2017233-2022-03547
    Event Type
    Injury
    Date Received
    December 6, 2022
    Date of Event
    August 12, 2022
    Report Date
    December 6, 2022
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    PRL
    PMA / PMN Number
    P160021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CBAS® HEPARIN SURFACE INCORPORATES CARMEDA HEPARIN MANUFACTURED FROM HEPARIN SODIUM API, WHICH IS COVALENTLY BOUND TO THE DEVICE SURFACE AND IS ESSENTIALLY NON-ELUTING. (B)(4). THE FOLLOWING LITERATURE WAS REVIEWED: THREE CASES OF INTERNAL ILIAC ARTERY RECONSTRUCTION USING IBE, VBX, AND VIABAHN FOR BILATERAL ILIAC ARTERY ANEURYSMS. TARO NAKAZATO, ET AL. THE JAPANESE JOURNAL OF VASCULAR SURGERY. 2022: 31(SUPPL.) P.P14-1. W. L. GORE & ASSOCIATES, INC. (GORE) IS SUBMITTING THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY GORE, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. BLANK FIELDS PRESENT ON THIS REPORT INCLUDE REQUIRED FIELDS AND FIELDS DETERMINED TO BE NOT APPLICABLE. BLANK REQUIRED FIELDS INDICATE THAT THE INFORMATION WAS NOT PROVIDED, WAS DEEMED UNAVAILABLE OR WAS NOT APPLICABLE. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, GORE, OR ITS ASSOCIATES THAT THE DEVICE, GORE OR ITS ASSOCIATES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE A LEGAL ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY DEFECTS OR HAS MALFUNCTIONED, AS DEFINED FROM A LEGAL STANDPOINT. THESE WORDS ARE INCLUDED IN THE REPORT AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA, TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REPORTING PURSUANT TO PART 803. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT.

    Description of Event or Problem · 0

    THE FOLLOWING LITERATURE WAS REVIEWED: THREE CASES OF INTERNAL ILIAC ARTERY RECONSTRUCTION USING IBE, VBX, AND VIABAHN FOR BILATERAL ILIAC ARTERY ANEURYSMS. TARO NAKAZATO, ET AL. THE JAPANESE JOURNAL OF VASCULAR SURGERY. 2022: 31(SUPPL.) P.P14-1. [CASE 2] A 79 YEAR-OLD MALE PATIENT WITH A 53 MM LEFT COMMON ILIAC ARTERY ANEURYSM AND BILATERAL INTERNAL ILIAC ARTERY ANEURYSMS (RIGHT 36 MM, LEFT 45 MM) UNDERWENT AN EVAR PROCEDURE AND GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS (IBE) WAS INDICATED. THE RIGHT HYPOGASTRIC ARTERY ANEURYSM WAS EXCLUDED USING AN 8MM X 79MM GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICE). THE LEFT HYPOGASTRIC ARTERY WAS RECONSTRUCTED USING AN IBE DEVICE, AN 8MM X 59MM VBX DEVICE AND AN 8MM X 5CM GORE® VIABAHN® ENDOPROSTHESIS. FINAL ANGIOGRAPHY SHOWED BLOOD FLOW INTO THE BILATERAL INTERNAL ILIAC ARTERIES. A CT SCAN AT ONE WEEK POST PROCEDURE SHOWED THE LEFT HYPOGASTRIC ARTERY WAS OCCLUDED. BLOOD FLOW INTO THE RIGHT INTERNAL ILIAC ARTERY WAS MAINTAINED. THERE WERE NO SIGNS OF PELVIC ISCHEMIA IN THE PERIOPERATIVE PERIOD. THE PATIENT WAS DISCHARGED ON POSTOPERATIVE DAY 9. IT WAS UNKNOWN WHICH DEVICE WAS OCCLUDED IN THE LEFT SIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2541143 GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS ILIAC COVERED STENT, ARTERIAL PRL W. L. GORE & ASSOCIATES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Male Other| R